- The U.S. Food and Drug Administration on Monday approved the first biosimilar version of Lucentis, a blockbuster biologic drug for age-related macular degeneration and two other eye conditions. The biosimilar, called Byooviz, was developed by Samsung Bioepis and will be sold by partner Biogen when patents protecting Lucentis expire next year.
- Byooviz is the second biosimilar to be approved in the U.S. in 2021 after the agency cleared Mylan and Biocon’s Semglee as interchangeable with Sanofi’s Lantus. The FDA approved three biosimilars last year and to date has approved 31 of the copycat drugs.
- There are two types of AMD, which causes vision loss and can affect daily activities such as reading, driving and watching television. Dry AMD is more common, but wet AMD accelerates vision loss. Byooviz has already been cleared in Europe and the U.K.
Biosimilar approvals have become rarer since 2019, when the FDA approved a record 10 of the copycat biologics. In a press release, the agency said Byooviz’s approval was based on evidence that found “comparative clinical efficacy and safety” between the biosimilar and Lucentis.
Approximately 11 million people in the U.S. are affected by AMD, according to Samsung Bioepis.
Biosimilars are promoted as a way to save on the substantial costs associated with wide use of pricey biologic drugs like Humira, Enbrel and Lucentis. But their impact in the U.S. has been muted, due in part to more modest discounts than those offered for generic drugs and to broad patent estates protecting many biologic drugs.
Due to patents held by Genentech, Byooviz will not be launched in the U.S. until June 2022. Nine other FDA-approved biosimilars are blocked from launching on the market due to existing patents.
Lucentis was developed by Roche’s subsidiary Genentech and approved by the FDA in 2006, although the drug is marketed by Novartis across Europe. In Sept. 2020, the two companies were at the center of a marketing controversy and fined a collective $526 million by the French Competition Authority for alleged anti-competitive practices by promoting Lucentis over Roche’s cheaper drug Avastin, which can be used off-label to treat AMD.
In response to the investigation, which took the French authority six years, Novartis told FiercePharma last year that the decision was a “gross misinterpretation of the facts and a distortion of previous case law that is not intended to cover the situation in this case.”